In short
Clinical trials investigating Ibuprofen Sodium Dihydrate are studying treatment in patients with symptomatic uncomplicated upper respiratory tract infections with wet cough. The trial data focus on whether the study treatment is effective and safe, and on how quickly symptoms improve. These studies involve adults with upper respiratory tract infections.
Key points
- Clinical trials investigating Ibuprofen Sodium Dihydrate are focused on symptomatic uncomplicated upper respiratory tract infections with wet cough. The main study is a Phase 3 trial that planned to compare a fixed-dose combination treatment with its separate components. Researchers wanted to see whether symptoms improved faster and to assess safety. The main result measured the time until cough, fever, cold symptoms, and total symptom scores became mild or better. The trial was planned for 483 participants but was withdrawn before completion.
Trial overview
The available trial studied a fixed-dose combination with Ibuprofen Sodium Dihydrate and N-acetylcysteine in patients with symptomatic uncomplicated upper respiratory tract infections with wet cough. The study aimed to test whether the combination worked better than the separate components given alone, and it also looked at safety.
Study design and treatment groups
This was a randomized, multi-centre, double-blind, double-dummy, parallel-group clinical study. In simple terms, people were assigned by chance to different groups, the study was run at more than one center, and neither the patients nor the study team knew which treatment was being used.
The trial compared the fixed-dose combination with its individual components, meaning ibuprofen monotherapy and N-acetylcysteine monotherapy. The trial record also lists matching placebo treatments, which are inactive look-alike products used to keep the study blinded.
Who could participate
The target population was patients with symptomatic uncomplicated upper respiratory tract infections and wet cough. The record does not give more detailed age limits or other eligibility rules in the provided data.
What was measured
The main endpoint was the time from randomization to clinically significant improvement of signs and symptoms of uncomplicated upper respiratory tract infection with wet cough. Improvement was defined as a score of 1 or less on a 5-point Likert scale, where lower scores mean fewer symptoms.
The symptoms assessed were cough, fever, cold symptoms, and the total symptom score. Fever was specifically defined in the trial data as axillary temperature of at least 37.5 °C.
The brief summary says the efficacy goal was to show that 7 days of treatment with the fixed-dose combination was better than the separate components in reaching symptom improvement, and the safety goal was to assess the safety of the investigational products throughout the trial.
Trial status and enrollment
The study was a Phase 3 trial, which is a later-stage study that usually checks how well a treatment works and how safe it is in a larger group of patients. The planned enrollment was 483 participants.
The trial status was Withdrawn, meaning the study was stopped before completion.